Use of Virtual Reality for Surgical Planning in Neuroblastoma

NCT05781919 | Unknown

• 1 other identifier: PIC-44-23
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

Neuroblastoma is one of the most common extracranial solid tumors in children. It originates from cells of the neural crest, and can be located at the adrenal level, or in the sympathetic chains from the neck to the pelvis. Surgery still remains a mainstay part of the treatment and this is particularly challenging when IDRF are present. Adequate surgical planning, based on images such as CT Scans, MRI and/or nuclear medicine is crucial. This project seeks to compare; surgical time, GTR percentage and complications between standard surgical planning with biplanar 2D images vs the use of virtual reality as a planning tool, through the segmentation and post-processing of medical images and the visualization of 3D models with immersive virtual reality glasses (VR). The software that will be used for the segmentation and generation of 3D images will be Materialise Mimics® Innovation Suite and the images can be viewed using the Meta Quest 2® virtual reality glasses and the Materialise Mimics Viewer® software, which sends the processed images to be seen only by the treating surgeon, without patient data. The study design will be of the type of multicenter clinical trial, controlled and with simple randomization. All patients with a debut diagnosis of neuroblastoma in stage L1, L2 or M who have a surgical indication will be recruited. Surgical time, complications, amount of resection (GTR), surgeon's satisfaction as well as surgical anatomy comprehension will be compared. An invitation to participate will be sent to hospitals around the world.

Conditions

Neuroblastoma

Keywords

virtual reality; neuroblastoma; surgery; planning; cancer; childhood

Outcome Measures

Primary Outcomes (1)

• Surgical time

  Reduction in surgical time when iVR is used

  From date of randomization until three months after surgery

Study Arms (2)

Group A

EXPERIMENTAL

Patients with L1, L2 or M INRGSS neuroblastoma in which their surgical planning will be performed using gold standard imaging (TC and/or MRI) and immersive virtual reality HMD device.

Other: Immersive virtual reality imaging

Group B

ACTIVE COMPARATOR

Patients with L1, L2 or M INRGSS neuroblastoma in which their surgical planning will be performed using only gold standard imaging (TC and/or MRI)

Other: Gold standard imaging

Interventions

Immersive virtual reality imaging OTHER

Segmentation and post-processing of DICOM 2D imaging will generate a 3D file able to be used in immersive virtual reality googles, for further analysis of the tumor and anatomic structures that could facilitate surgical planning.

Group A

Gold standard imaging OTHER

Use of traditional gold standard 2D imaging (TC and/or MRI) for surgical planning

Group B

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Pediatric patients (0-18 years) with neuroblastoma in L1, L2 or M stages (INGRSS) who have surgical indication for resection.

You may not qualify if:

• Patients with relapsed neuroblastoma.
• Patients with neuroblastoma other than abdominal or pelvic location.
• Patients with previous surgery for the current diagnosis of neuroblastoma (excluding the biopsy that made the diagnosis).
• Patients who have undergone laparoscopic surgery.
• Patients operated on by a surgical team other than the one that usually treats oncology children at your center.
• Failure to obtain informed consent.
• Lack of complete medical records.

Sponsors & Collaborators

• Hospital Sant Joan de Deu: lead

Study Sites (1)

Hospital Sant Joan de Déu

Esplugues de Llobregat, Barcelona, 08095, Spain

RECRUITING

MeSH Terms

Conditions

Neuroblastoma; Neoplasms

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Lucas Krauel, PhD

  Hospital Sant Joan de Deu

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Albert Pasten, MD

CONTACT

671589972; apastego44@alumnes.ub.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2023
• First Posted: March 23, 2023
• Study Start: June 1, 2023
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2025
• Last Updated: May 3, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)